Constituent Update

April 17, 2019

The U.S. Food and Drug Administration issued a draft guidance today to provide its current view on the declaration of carbohydrates, total sugars and added sugars for products that contain allulose, a sweetener, on the Nutrition Facts label. The draft guidance also provides FDA’s current view on calculating the caloric value of allulose. The guidance is designed to assist manufacturers in complying with the Nutrition Facts label requirements.

FDA is advising manufacturers that it intends to exercise enforcement discretion regarding the requirement that the sweetener allulose be included in the amount of Total Sugars and Added Sugars on the Nutrition Facts label. However, allulose still must be included in the amount of Total Carbohydrates. The draft guidance also advises manufacturers of its intent to exercise enforcement discretion regarding the use of 4 calories per gram of sweetener to calculate the caloric contribution of allulose and instead, allow manufacturers to use a caloric value of 0.4 calories per gram to calculate the caloric contribution of allulose.

Allulose is a low-calorie sweetener that is naturally occurring in small amounts in wheat, fruits such as raisins and dried figs, and in other sweet foods such as brown sugar and molasses. It can also be manufactured. While allulose has a chemical structure similar to other sugars, it is not metabolized by the body in the same way as most sugars and does not contribute the same number of calories.

Under FDA’s 2016 Nutrition Facts label rule, allulose must be included in declarations for Total Carbohydrates, Total Sugars, and Added Sugars. Current requirements also require allulose to be counted as 4 calories per gram of the sweetener. However, FDA stated in the final rule that additional time was needed to fully consider the science as to whether allulose should be excluded from these requirements. FDA has received several petitions related, in part, to whether allulose should be exempt from being included as a carbohydrate, sugar or added sugar and to the caloric value of allulose. This draft guidance conveys FDA’s current thinking regarding allulose.

FDA will soon release other guidance documents regarding FDA’s current views on the Nutrition Facts label requirements. As an example, FDA will finalize its draft guidance on declaring added sugars on honey, maple syrup and certain cranberry products.

Comments on the draft guidance should be submitted within 60 days after publication in the Federal Register of the notice announcing the availability of the guidance to ensure that they are considered before work begins on the final guidance. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2019-D-0725.